2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial

NCT02320578CompletedNAINTERVENTIONAL

Summary

The aim of this prospective randomized pilot study is to verify if the operative time of a Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard laparoscopy

Key Facts

Lead Sponsor

Catholic University of the Sacred Heart

Enrollment

26

Start Date

2014-10-01

Completion Date

2015-03-01

Study Type

INTERVENTIONAL

Official Title

Prospective Randomized Trial on2D Versus 3D Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response.

Interventions

3D LaparoscopyStandard Laparoscopy

Conditions

Uterine Cervical NeoplasmsLaparoscopic Surgical Procedures

Eligibility

Sex

FEMALE

* Age ≤ 75 years
* Patient's informed consent
* American Society of Anesthesiologists: \< class III or IV
* No actual pregnancies or P.I.D.
* No previous major abdominal surgical procedures
* Early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to NACT with complete clinical response
* No previous radiotherapy on the pelvic field
* No uterine size larger than conform 10 weeks gestation

Outcome Measures

Primary Outcomes

Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy

Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses

Time frame: Intraoperative

Secondary Outcomes

Number of participants with intra or post operative complications

Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele

Time frame: two years

Locations

Catholic University of the Sacred Heart, Rome, Italy

2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial